SCLCPhase 2NCT01797874
Pazopanib Maintenance for SCLC
A Phase 2 study testing Pazopanib in people with SCLC, run by Samsung Medical Center at 1 site in South Korea.
Trial summary
To evaluate the efficacy of pazopanib maintenance after 1st line CTx for SCLC. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- SCLC
- What is being tested?
- Pazopanib
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 97 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jun 2013to Dec 2017
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- histologically confirmed SCLC
- no disease progression after 4 cycles of etoposide/platinum 1st-line therapy
- history of 4 cycles of etoposide/platinum 1st-line therapy
- between 21 days and 42 days since C4D1 of etoposide/platinum
- no symptomatic brain meta
Who cannot join
- poor hepatic, renal function
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase II Study of Pazopanib Maintenance for SCLC
To evaluate the efficacy of pazopanib maintenance after 1st line CTx for SCLC.
- Conditions
- SCLC
- Being tested
- Pazopanib, Placebo
- Keywords
- pazopanib maintenance, efficacy, SCLC
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PazopanibDrug
Also called Votrient
Experimental
PlaceboDrug
placebo arm
| Study group | Role | What they receive |
|---|---|---|
| Pazopanib | Experimental | pazopanib maintenance after 4 cycles of etoposide/platinum in SCLC Receives: Drug: Pazopanib |
| placebo | Placebo comparator | placebo after 4 cycles of etoposide/platinum chemotherapy in SCLC Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2013 (estimated)
- Study startJun 2013
- Primary completionFeb 2017
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SCLCStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 97 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Myung-Ju Ahn, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01797874
- Sponsor's protocol ID
- 2012-09-060-002
- Status last verified
- Dec 2019
- First submitted
- 21 Feb 2013
- Last updated
- 9 Dec 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Pazopanib Maintenance for SCLC
- ClinicalTrials.gov ID
- NCT01797874
- Acronym / sponsor ID
- 2012-09-060-002
- Conditions
- SCLC
- Keywords
- pazopanib maintenance, efficacy, SCLC
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 97 participants (actual)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- Jun 2013 (actual)
- Primary completion
- Feb 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 25 Feb 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the efficacy of pazopanib maintenance after 1st line CTx for SCLC.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pazopanib | Experimental | Drug: Pazopanibpazopanib maintenance after 4 cycles of etoposide/platinum in SCLC |
| placebo | Placebo comparator | Drug: Placeboplacebo after 4 cycles of etoposide/platinum chemotherapy in SCLC |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- histologically confirmed SCLC
- no disease progression after 4 cycles of etoposide/platinum 1st-line therapy
- history of 4 cycles of etoposide/platinum 1st-line therapy
- between 21 days and 42 days since C4D1 of etoposide/platinum
- no symptomatic brain meta
Key exclusion criteria (1 listed)
- poor hepatic, renal function
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PazopanibAlso: VotrientExperimental | Drug | Pazopanib |
| Placeboplacebo arm | Drug | placebo |
Primary outcome
Progression-free survival
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Pazopanib in people with SCLC, run by Samsung Medical Center at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2019.